3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.

Summary

Purpose of the Study When a child loses a "baby" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer.

This study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide.

The Three Study Groups

Children in this study are randomly assigned to one of three groups:

1. 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.
2. Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.
3. Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.

What is Being Measured?

Researchers are following the children for 12 months to track:

Survival: Which appliance stays glued in and doesn't break most effectively?

Time: How much time does the dentist spend making and fitting the appliance?

Comfort: How much discomfort or pain did the child feel during the process?

Health: Does the appliance cause any irritation to the gums or surrounding teeth?

Who Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile.

Importance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.

Conditions

• Space Maintenance
• Tooth Loss / Rehabilitation

Interventions

DEVICE

3D-Printed Custom Space Maintainer

A digitally designed, monolithic space maintainer. The workflow involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The device is fabricated using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin. It is bonded to the abutment tooth using a light-cured orthodontic adhesive

DEVICE

Conventional Band-and-Loop Space Maintainer

The traditional clinical reference standard. It is fabricated using an analog workflow: an alginate impression is taken to create a stone model, a stainless steel band (3M Unitek) is fitted to the model, and a 0.036-inch stainless steel wire is hand-contoured and silver-soldered to the band. The appliance is polished and cemented with glass ionomer cement.

DEVICE

Denovo Chairside Space Maintainer

A prefabricated, stainless steel space maintainer system (Denovo Dental) designed for immediate application. A pre-sized band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is adjusted for length at the chairside and mechanically secured to the band using a specialized crimping and locking tool, requiring no laboratory soldering. It is cemented during the initial appointment.

Sponsors & Collaborators

• Murad Alrashidi

  lead OTHER

Principal Investigators

• MURAD ALRASHIDI, BDS, MSC · Qassim University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-06-30

Completion

2027-07-31

FDA Device

Yes

Countries

• Saudi Arabia

Study Locations